Note: Ingredients listed on restricted chemical lists
EC/CAS
9004-65-3
Name of the chemical
methylhydroxypropylcellulose
Concentration
N/A
EC/CAS
14807-96-6
Name of the chemical
Talc
Concentration
N/A
EC/CAS
13463-67-7
Name of the chemical
Reaction mass of titanium dioxide and silver chloride
Concentration
N/A
EC/CAS
238-877-9
Name of the chemical
Talc: Hydrated magnesium silicate
Concentration
N/A
EC/CAS
236-675-5
Name of the chemical
Titandioxid; [in Pulverform mit mindestens 1 % Partikel mit aerodynamischem Durchmesser ≤ 10 μm] (2020/217)
Concentration
N/A
EC/CAS
209-150-3
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
N/A
General Information
Revision date
2020-07-08
Product name
RUKOBIA EXTENDED RELEASE TABLETS
Product Synonyms
FOSTEMSAVIR 600 MG EXTENDED RELEASE TABLETS * BMS-663068 ER TABLETS 600 MG *
Emergency telephone
VERISK 3E GLOBAL INCIDENT RESPONSE
Icons in SDS
Company Information
company name
GlaxoSmithKline UK
e-mail address of the competent person responsible for the Safety Data Sheet
msds@gsk.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H317, H373
Hazard statements
Code
Statements
H317
May cause an allergic skin reaction
Section 2
EU Classification
Regulation (EC) No 1272/2008 as amended This mixture does not meet the criteria for classification according to Regulation (EC) 1272/2008 as amended.
Health hazards
Skin sensitisation Category 1B H317 - May cause an allergic skin reaction. Specific target organ toxicity - repeated Category 2 H373 - May cause damage to exposure organs through prolonged or repeated exposure. Hazard summary May cause damage to organs through prolonged or repeated exposure. May cause an allergic skin reaction. Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.
2.2 Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains
FOSTEMSAVIR, HYDROXYPROPYL METHYL CELLULOSE, MAGNESIUM STEARATE, Talc, Titanium dioxide
Signal word
Warning
Hazard statements
H317 May cause an allergic skin reaction. H373 May cause damage to organs through prolonged or repeated exposure.
Prevention
P260 Do not breathe dust/fume/gas/mist/vapours/spray. P272 Contaminated work clothing should not be allowed out of the workplace. P280 Wear protective gloves.
Response
P302 + P352 IF ON SKIN: Wash with plenty of water/. P314 Get medical advice/attention if you feel unwell. P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P362 + P364 Take off contaminated clothing and wash it before reuse.
Storage
Not available.
Disposal
P501 Dispose of contents/container (in accordance with related regulations).
Supplemental label elements
20.972 % of the mixture consists of component(s) of unknown acute oral toxicity. 97.472 % of the mixture consists of component(s) of unknown acute dermal toxicity. 97.472 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 97.472 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.
2.3 Other hazards
Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.
